Published Technical Documents
Standards, guidance and application literature from the bodies and manufacturers that publish it. Every entry links to the document page itself and quotes the sentence that says what it covers.
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U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202826. Device: IMMULITE® 2000 Cortisol. Applicant as listed: Siemens Healthcare Diagnostics Products, Ltd.. Decision date: 2021-01-15.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203270. Device: IMMULITE/IMMULITE® 1000 Cortisol. Applicant as listed: Siemens Healthcare Diagnostics Products, Ltd.. Decision date: 2021-01-15.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202408. Device: cobas CTNG for use on cobas 6800/8800 systems. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2021-01-21.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203220. Device: cobas BKV. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2021-01-29.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210272. Device: LIAISON Anti-HAV. Applicant as listed: DiaSorin, Inc.. Decision date: 2021-02-09.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202573. Device: LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus. Applicant as listed: DiaSorin, Inc.. Decision date: 2021-02-18.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202574. Device: LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus. Applicant as listed: DiaSorin, Inc.. Decision date: 2021-02-18.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202188. Device: Safety Blood Collection Sets for Single Use. Applicant as listed: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Decision date: 2021-02-19.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201674. Device: Cultura Collection and Transport System. Applicant as listed: Merit Medical Systems, Inc.. Decision date: 2021-03-03.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203295. Device: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit. Applicant as listed: Gold Standard Diagnostics. Decision date: 2021-03-22.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203612. Device: Capture-CMV. Applicant as listed: Immucor, Inc.. Decision date: 2021-03-22.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203296. Device: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit. Applicant as listed: Gold Standard Diagnostics. Decision date: 2021-03-22.
Source: api.fda.gov · Retrieved 2026-10-19
Key takeaways
Every item here is a technical document its publisher made public: a standards-body scope page, a regulator guidance document, or a manufacturer application note or journal article. The entry links to that page and quotes the sentence describing what the document covers. It is not a record of work IVDmap has done.
Target audienceImplementation teams, labs, procurement managers
Review and references
Compiled from public manufacturer materials and regulatory sources. Not independently verified and not reviewed by a named clinician.
2026-10-01
2026-10-09
professional use
Every document below is published by the body named on it, and this page links to that page. Nothing here is a record of work IVDmap has done.